Echo Therapeutics has reported positive results from its clinical study of its Symphony tCGM System in patients with type 1 and type 2 diabetes. Data from the study confirm that Symphony successfully monitors the broad range of blood glucose values seen in people with diabetes.
Using over 2,600 Symphony tCGM glucose readings from the twenty (20) study
subjects paired with reference blood glucose measurements, CG-EGA showed
that 94.4% of the readings were clinically accurate and 2.5% were benign errors with a combined A+B of 96.9%. The MARD for the study was 12.6%.
Values for blood glucose measurements ranged from 38 to 399 mg/dL. There
were no adverse events reported from the Prelude skin permeation or the
Symphony tCGM biosensor.
The feasibility study was designed to evaluate the performance of the
Symphony tCGM System in an outpatient setting at a clinical research
organization. Twenty (20) adult subjects with type 1 or type 2 diabetes
were evaluated. The skin of each subject was prepared using Prelude and a
Symphony tCGM biosensor was applied to the skin site. Venous reference
blood samples were taken from intravenous lines at 15-minute intervals for
24 hours and measured on a YSI 2300 STAT Plus Glucose Analyzer. The study data was blinded to study subjects and study personnel. At the conclusion of the 24-hour study period, the test skin sites were inspected for
redness or other undesirable effects.